Blog

Standard Operating Procedure (SOP) for Batch Size Determination according to the chain of production equipment and equipment capacity. Batch Size determination based on the risk assessment. 

Procedure for Determination of Batch Size

1.0      PURPOSE:

• • This Standard Operating Procedure (SOP) describes in detail the procedure to be followed for the determination of the batch size of products to be manufactured.

2.0      SCOPE:

• • This SOP is applicable to all products for the determination of its batch size at pharmaceuticals drug manufacturing plants.

3.0      REFERENCES:

• • In House

• • SOP for Quality Risk Management

4.0      RESPONSIBILITY- SOP FOR BATCH SIZE DETERMINATION:

• • Head -Production shall design the batch size based on equipment capacity.

• • Production Head/ Designee shall assess the risk as per SOP for Quality Risk Management.

• • The production officer shall ensure the manufacturing process as per equipment capacity.

• • QA shall issue BMR as per the batch size.

5.0      ABBREVIATIONS:

• • BMR: Batch Manufacturing Record

• • Dept: Department

• • NLT : Not Less Than

• • QA: Quality Assurance

• • SOP : Standard Operating Procedure

• • V/V : Volume / Volume

• • WIP : Wash In Process

• • DEFINITION: NA

7.0      PROCEDURE FOR BATCH SIZE DETERMINATION:

• • A basic principle for determining the batch size is the capacity of the equipment available.

• • The batch size of any product was decided should be within the minimum and the maximum capacity of the equipment, to be utilized for the product.

• • The 100% occupancy of the equipment, calculated assuming the average bulk density of 0.5 gm/ml with respect to the standard capacity of the equipment.

• • For example maximum occupancy for 200 litre equipment shall be calculated as 200 litre x 0.5 gm/ml = 100.00 Kg.

• • Note: Capacity of equipment may vary, depending upon bulk density of materials or granules or tablets and nature of product.

• • The minimum and maximum capacity of the equipment taken basically like 20% and 80% respectively of the equipment occupancy.

• • In order to calculate the minimum and maximum capacity theoretically,

• • The following are some examples given for RMG, Bunker, and Drum mixer.

• • Calculation for RMG of 100 Lit capacity is as follows:

• • 100% occupancy of equipment: 100 Lit × 0.5 gm/ml=50 kg.

• • The minimum capacity of equipment: 50 Kg x 20% = 10 Kg.

• • The maximum capacity of equipment: 50 Kg x 80% = 40 Kg.

• • Calculation for RMG of 600 Lit capacity is as follows:

• • 100% occupancy of equipment: 600 Lit × 0.5 gm/ml=300 kg.

• • The minimum capacity of equipment: 300 Kg x 20% = 60 Kg.

• • The maximum capacity of equipment: 300 Kg x 80% = 240 Kg.

• • The calculation for Bunker of 300 Lit capacity is as follows:

• • 100% occupancy of equipment: 300 Lit × 0.5 gm/ml=150 kg.

• • The minimum capacity of the bunker: 150 Kg x 20% = 30 Kg.

• • The maximum capacity of the bunker: 150 Kg x 80% = 120 Kg.

• • The calculation for Bunker of 1200 Lit capacity is as follows:

• • 100% occupancy of equipment: 1200 Lit × 0.5 gm/ml=600 kg.

• • The minimum capacity of the bunker: 600 Kg x 20% = 120 Kg.

• • The maximum capacity of the bunker: 600 Kg x 80% = 480 Kg.

• • The calculation for Drum mixer of 200 Lit capacity is as follows:

• • 100% occupancy of equipment: 200 Lit × 0.5 gm/ml=100 kg.

• • The minimum capacity of the bunker: 100 Kg x 20% = 20 Kg.

• • The maximum capacity of the bunker: 100 Kg x 80% = 80 Kg.

• • The equipment capacity for coating pan can be vary depending upon the tablet size, shape of tablets and bulk density of core tablets.

• • The minimum and maximum batch size for coating pan, approximately are as follows:

• • 1.      For 24” coating pan 8 – 15 Kg.

• • 2.      For 32” coating pan 20 – 40 Kg.

• • 3.      For 36” coating pan 35 – 55 Kg.

• • 4.      For 37” coating pan 30 – 100 Kg.

• • 5.      For 48” coating pan 90 – 170 Kg.

• • 6.      For 60” coating pan 170 – 330 Kg.